Catalog Number

A001017

Brand Name

AtriClip FLEX•V

Version/Model Number

ACHV35

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FZP

Product Code Name

Clip, Implantable

Public Device Record Key

ea1b1b86-dd0d-4b21-bc3c-be04ab6d329c

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

February 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-